Telmisartan/Hydrochloorthiazide Sandoz 80 mg/12,5 mg, omhulde tabletten

Telmisartan/Hydrochloorthiazide Sandoz is a combination of two active substances, telmisartan and hydrochlorothiazide in one coated tablet. Both of these substances help to control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Telmisartan/Hydrochloorthiazide Sandoz is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.

Telmisartan/Hydrochloorthiazide Sandoz is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by Telmisartan/Hydrochloorthiazide Sandoz 80/12.5 mg or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.

Do NOT take Telmisartan/Hydrochloorthiazide Sandoz

• if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (It is also better to avoid Telmisartan/Hydrochloorthiazide Sandoz in early pregnancy – see pregnancy section.)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder) or any other severe liver disease.
• if you have severe kidney disease.
• if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan/Hydrochloorthiazide Sandoz.

Warnings and precautions

Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).

• Liver disease.
• Heart trouble.
• Diabetes.
• Gout.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body’s immune system attacks the body.
• The active ingredient hydrochlorothiazide can cause an unusual reaction, resulting in a decrease in vision and eye pain. These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Telmisartan /hydrochlorothiazide. This can lead to permanent vision loss, if not treated.

You must tell your doctor if you think you are (or might become) pregnant. Telmisartan/Hydrochloorthiazide Sandoz is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor.

You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.

In case of surgery or anaesthetics, you should tell your doctor that you are taking Telmisartan/Hydrochloorthiazide Sandoz.

Telmisartan/Hydrochloorthiazide Sandozmay be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Telmisartan/Hydrochloorthiazide Sandoz in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Telmisartan/Hydrochloorthiazide Sandoz:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Telmisartan/Hydrochloorthiazide Sandoz:

• Lithium containing medicines to treat some types of depression.
• Medicines associated with low blood potassium (hypokalaemia) such as other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors that may increase blood potassium levels.
• Heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide).
• Medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine).
• Other medicines used to treat high blood pressure, steroids, painkillers, medicines to treat cancer, gout, or arthritis, and vitamin D supplements.

Telmisartan/Hydrochloorthiazide Sandoz may increase the blood pressure lowering effect of other medicines and you should consult with your doctor if you need to adjust the dose of your other medicine while taking Telmisartan/Hydrochloorthiazide Sandoz.

The effect of Telmisartan/Hydrochloorthiazide Sandoz may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Telmisartan/Hydrochloorthiazide Sandoz before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan/Hydrochloorthiazide Sandoz. Telmisartan/Hydrochloorthiazide Sandoz is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan/Hydrochloorthiazide Sandoz is not recommended for mothers who are breast- feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Some people feel dizzy or tired when taking Telmisartan/Hydrochloorthiazide Sandoz. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan/Hydrochloorthiazide Sandoz contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking Telmisartan/Hydrochloorthiazide Sandoz.

Always take Telmisartan/Hydrochloorthiazide Sandoz exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose of Telmisartan/Hydrochloorthiazide Sandoz is one coated tablet a day. Try to take a coated tablet at the same time each day. You can take Telmisartan/Hydrochloorthiazide Sandoz with or without food. The coated tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Telmisartan/Hydrochloorthiazide Sandoz every day until your doctor tells you otherwise.

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If you take more Telmisartan/Hydrochloorthiazide Sandoz than you should

If you accidentally take too many coated tablets contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Telmisartan/Hydrochloorthiazide Sandoz

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your coated tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

If you have further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called "blood poisoning"), is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis has been observed with telmisartan only, however cannot be ruled out for Telmisartan/Hydrochloorthiazide Sandoz.

Possible side effects of Telmisartan/Hydrochloorthiazide Sandoz:

Common side effects (may affect up to 1 in 10 people):

• dizziness

Uncommon side effects (may affect up to 1 in 100 people):

• decreased blood potassium levels
• anxiety
• fainting (syncope)
• sensation of tingling
• pins and needles (paraesthesia)
• feeling of spinning (vertigo)
• fast heart beat (tachycardia)
• heart rhythm disorders
• low blood pressure
• a sudden fall in blood pressure when you stand up
• shortness of breath (dyspnoea)
• diarrhea
• dry mouth
• flatulence
• back pain
• muscle spasm
• muscle pain
• erectile dysfunction (inability to get or keep an erection)
• chest pain
• increased blood uric acid levels.

Rare side effects (may affect up to 1 in 1,000 people):

• Inflammation of the lung (bronchitis)
• activation or worsening of systemic lupus erythematosus (a disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and fever)
• sore throat
• inflamed sinuses
• feeling sad (depression)
• difficulty falling asleep (insomnia)
• impaired vision
• difficulty breathing
• abdominal pain
• constipation
• bloating (dyspepsia)
• feeling sick
• inflammation of the stomach (gastritis)
• abnormal liver function (Japanese patients are more likely to experience this side effect)
• rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome)

• redness of the skin (erythema)
• allergic reactions such as itching or rash
• increased sweating
• hives (urticaria)
• joint pain (arthralgia) and pain in extremities
• muscle cramps
• flu-like-illness
• pain
• increased levels of uric acid
• low levels of sodium
• increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.

Adverse reactions reported with one of the individual components may be potential adverse reactions with Telmisartan/Hydrochloorthiazide Sandoz, even if not observed in clinical trials with this product.

Telmisartan

In patients taking telmisartan alone the following additional side effects have been reported:

Uncommon side effects (may affect up to 1 in 100 people):

Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.

Rare side effects (may affect up to 1 in 1,000 people):

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, decreased haemoglobin (a blood protein), somnolence.

Very rare side effects (may affect up to 1 in 10,000 people):

Progressive scarring of lung tissue (interstitial lung disease)**

* The event may have happened by chance or could be related to a mechanism currently not known.

**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone the following additional side effects have been reported:

Side effects of unknown frequency (frequency cannot be estimated from the available data): Inflammation of the salivary gland, decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia), serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body’s immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased levels of glucose, or fat in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side affects you can help provide more information on the safety of this medicine.

[*For the printed material, please refer to the guidance of the annotated QRD template.]

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. This medicine does not require any special temperature storage conditions.

Do not use this medicine if you notice change in appearance in any way.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

What Telmisartan/Hydrochloorthiazide Sandoz contains

The active substances are telmisartan and hydrochlorothiazidede

Telmisartan/Hydrochloorthiazide Sandoz 40/12,5 mg omhulde tabletten

Each coated tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.

Telmisartan/Hydrochloorthiazide Sandoz 80/12,5 mg omhulde tabletten

Each coated tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.

Telmisartan/Hydrochloorthiazide Sandoz 80/25 mg omhulde tabletten

Each coated tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.

The other ingredients are:

Telmisartan/Hydrochloorthiazide Sandoz 40/12,5 mg omhulde tabletten

Tablet core: Sodium Hydroxide, Meglumine, Povidone K25 (E1201), Lactose monohydrate, Povidone K30 (E1201), Crospovidone (type A) (E1202), Lactose anhydrous, Magnesium stearate (E572)

Coating: Polivinyl alcohol units (E1203, Polyethylene glycol (E1521), Anhydrous colloidal silica (E551), Citric acid monohydrate (E330 )

Iron oxide yellow (E172), Iron oxide red (E172)

Telmisartan/Hydrochloorthiazide Sandoz 80/12,5 mg omhulde tabletten

Tablet core: Sodium Hydroxide, Meglumine, Povidone K25 (E1201), Lactose monohydrate, Povidone K30 (E1201), Crospovidone (type A) (E1202), Lactose anhydrous, Magnesium stearate (E572)

Coating: Polivinyl alcohol units (E1203), Polyethylene glycol (E1521), Anhydrous colloidal silica (E551), Citric acid monohydrate (E330)

Telmisartan/Hydrochloorthiazide Sandoz 80/25 mg omhulde tabletten

Tablet core: Sodium Hydroxide, Meglumine

Povidone K25 (E1201), Lactose monohydrate

Povidone (E1201), Crospovidone (type A) (E1202), Lactose anhydrous, Magnesium stearate Coating: Polivinyl alcohol units (E1203, Polyethylene glycol (E1521), Anhydrous colloidal silica (E551), Citric acid monohydrate (E330), Iron oxide yellow (E172)

For further information on lactose see end of section 2

What Telmisartan/Hydrochloorthiazide Sandoz looks like and contents of the pack

Telmisartan/Hydrochloorthiazide Sandoz 40/12,5 mg omhulde tabletten

Red, oval, biconvex coated tablet debossed with 40 on one side and with 12.5 on the other side (12.4 mm x 6.2 mm).

Telmisartan/Hydrochloorthiazide Sandoz 80/12,5 mg omhulde tabletten

White to off-white, oval, biconvex coated tablet debossed with 80 on one side and with 12.5 on the other side (15.4 mm x 8.0 mm).

Telmisartan/Hydrochloorthiazide Sandoz 80/25 mg omhulde tabletten

Yellow, oval, biconvex coated tablet debossed with 80 on one side and with 25 on the other side (15.4 mm x 8.0 mm).

Al/Al blisters containing 28 coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

Nederland

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana Slovenië

LEK S.A.

ul. Domaniewska 50 C 02-672 Warschau Polen

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Duitsland

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Roemenië

In het Register ingeschreven onder:

Telmisartan/Hydrochloorthiazide Sandoz 40 mg/12,5 mg, omhulde tabletten: RVG 111925 Telmisartan/Hydrochloorthiazide Sandoz 80 mg/12,5 mg, omhulde tabletten: RVG 111926 Telmisartan/Hydrochloorthiazide Sandoz 80 mg/25 mg, omhulde tabletten: RVG 111927

This medicinal product is authorised in the Member States of the EEA under the following names:

Netherlands	Telmisartan/Hydrochloorthiazide Sandoz 40 mg/12,5 mg,
	omhulde tabletten
	Telmisartan/Hydrochloorthiazide
	Sandoz 80 mg/12,5 mg, omhulde tabletten
	Telmisartan/Hydrochloorthiazide
	Sandoz 80 mg/25 mg, omhulde tabletten
Ierland	Telmisartan/hydrochlorothiazide
	Rowex 40 mg/12.5 mg Coated Tablets
	Telmisartan/hydrochlorothiazide
	Rowex 80 mg/12.5 mg Coated Tablets
	Telmisartan/hydrochlorothiazide
	Rowex 80 mg/25 mg Coated Tablets
Roemenië	Telmisartan/hidroclorotiazida
	Sandoz 80 mg/12,5 mg drajeuri
	Telmisartan/ hidroclorotiazida
	Sandoz 80 mg/25 mg drajeuri

This leaflet was last revised in November 2013.